Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide Developmental and Reproductive Toxicology: Version 1.1, 67355-67357 [2020-23393]
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Federal Register / Vol. 85, No. 205 / Thursday, October 22, 2020 / Notices
67355
TABLE 1—NOTICES OF UPDATES TO RECOGNIZED OR UPDATED SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA (STIC) BY
DRUG
Drug
Route of
administration
Action taken
Therapeutic
category
Azithromycin ........................
Oral, Injection .......
Antibacterial .........
6/10/19
Cefiderocol ..........................
Injection ................
Antibacterial .........
11/18/19
Ceftaroline fosamil ...............
Ceftolozane Tazobactam ....
Injection ................
Injection ................
Antibacterial .........
Antibacterial .........
8/29/19
6/10/19
Cefuroxime ..........................
Injection ................
Antibacterial .........
6/10/19
Ciprofloxacin ........................
Oral, Injection .......
Antibacterial .........
6/10/19
Colistimethate ......................
Injection ................
Antibacterial .........
6/10/19
Daptomycin ..........................
Injection ................
Antibacterial .........
6/10/19
Delafloxacin .........................
Imipenem-CilastatinRelebactam.
Lefamulin .............................
Levofloxacin .........................
Injection, Tablets ..
Injection ................
For Neisseria gonorrhoeae, STIC are not recognized at
this time. FDA review of these STIC is ongoing.
Added drug to antibacterial Susceptibility Test Interpretive Criteria web page. FDA identified STIC.
Typographical error corrected ..........................................
For Enterobacteriaceae, an exception to the recognized
standard is provided for Disk Diffusion. For
Haemophilus influenzae, the FDA-identified STIC are
provided. STIC are based on dosing regimens that
differ by the serious infection being treated, and this
information is provided.
For Neisseria gonorrhoeae, FDA agrees with the recognized standard that it is no longer appropriate to list
STIC.
For Enterobacteriaceae and Pseudomonas aeruginosa,
the updated standard is recognized.
For Pseudomonas aeruginosa and Acinetobacter spp.,
FDA has reviewed these STIC and concludes that
STIC cannot be recognized at this time.
For Enterococcus spp. (vancomycin-susceptible isolates
only), an exception to the recognized standard is provided. FDA review of these STIC is ongoing.
FDA identified STIC ..........................................................
FDA identified STIC ..........................................................
Antibacterial .........
Antibacterial .........
10/25/19
7/18/19
Antibacterial .........
Antibacterial .........
8/29/19
6/10/19
Meropenem .........................
Injection ................
Antibacterial .........
12/23/19
Meropenem- Vaborbactam ..
Injection ................
Antibacterial .........
6/10/19
Ofloxacin ..............................
Oral ......................
Antibacterial .........
6/10/19
Omeprazole magnesium,
Amoxicillin, and Rifabutin.
Pretomanid ..........................
Oral ......................
FDA identified STIC ..........................................................
For Enterobacteriaceae and Pseudomonas aeruginosa,
the updated standard is recognized.
For Acinetobacter spp., the updated standard is recognized.
For Enterobacteriaceae, the updated standard is recognized.
For Neisseria gonorrhoeae, FDA identified STIC are
provided. FDA review of these STIC is ongoing.
Added drug to antibacterial Susceptibility Test Interpretive Criteria web page. No STIC identified at this time.
Added drug to antibacterial Susceptibility Test Interpretive Criteria web page. No STIC identified at this time.
Antibacterial .........
11/18/19
Antibacterial .........
8/29/19
Oral, Injection .......
Oral, Injection .......
Oral ......................
Dated: October 19, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–23439 Filed 10–21–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1806]
Fit for Use Pilot Program Invitation for
the Clinical Data Interchange
Standards Consortium for Standard for
Exchange of Nonclinical Data
Implementation Guide Developmental
and Reproductive Toxicology: Version
1.1
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:35 Oct 21, 2020
Jkt 253001
The Food and Drug
Administration (FDA or Agency) is
announcing that it intends to conduct a
Fit for Use (FFU) pilot program to test
the processing and analysis of
nonclinical study data provided
electronically for the Clinical Data
Interchange Standards Consortium
(CDISC) for Standard for Exchange of
Nonclinical Data (SEND)
Implementation Guide (IG):
Developmental and Reproductive
Toxicology v1.1 (SEND–DART). The
Agency’s Center for Drug Evaluation
and Research (CDER) will test the
processing and analysis of nonclinical
study data provided electronically in
SEND–DART format. FDA is inviting
individual firms that wish to participate
in this pilot program to submit
participation requests via email or in
writing.
SUMMARY:
To be considered for
participation in the pilot program,
submit electronic or written requests by
DATES:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
Date
February 26, 2021. See the ADDRESSES
section for participation request
instructions.
Submit electronic requests
to participate in the pilot and comments
regarding this pilot project to Docket
No. FDA–2020–N–1806 at https://
www.regulations.gov. Submit written
requests to participate in the pilot and
comments regarding the pilot to Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
by February 26, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
ADDRESSES:
E:\FR\FM\22OCN1.SGM
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67356
Federal Register / Vol. 85, No. 205 / Thursday, October 22, 2020 / Notices
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–N–1806 for ‘‘Fit for Use Pilot
Program Invitation for the Clinical Data
Interchange Standards Consortium for
Standard for Exchange of Nonclinical
Data Implementation Guide:
Developmental and Reproductive
Toxicology v1.1.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
VerDate Sep<11>2014
17:35 Oct 21, 2020
Jkt 253001
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Jesse Anderson, Office of Computational
Science, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 21, Rm. 1553, Silver Spring,
MD 20993–0002, 301–348–1816,
Jesse.Anderson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Data Standards help FDA receive,
process, review and archive submission
data more efficiently and effectively.
Study data standards describe a
standard way to exchange clinical and
nonclinical research data between
computer systems. These standards
provide a consistent general framework
for organizing study data, including
templates for datasets, standard names
for variables, and a standard way of
doing calculations with common
variables. Study data standards are
required for study data submitted to
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
FDA’s CDER per the published
guidance.1
CDISC is an open, multidisciplinary,
nonprofit organization that has
established worldwide industry
standards to support the electronic
acquisition and submission of study
data and metadata for medical and
biopharmaceutical product
development.2 CDISC is currently
facilitating and testing the extension of
the SEND–DART standard for
nonclinical toxicology data.
CDER completed a pilot project
evaluating SEND 3.1 using SENDformatted sample toxicology datasets.
Phase 1 of the pilot supported the
development of a SEND Implementation
Guide (SENDIG) describing the process
for formatting data from single and
repeat-dose animal toxicity and
carcinogenicity studies for submission
purposes. During Phase 2 of the pilot,
CDER evaluated submission of SEND
formatted datasets and evaluated data
validation and analysis tools
capabilities. The outcomes of this pilot
resulted in improvements to the
SENDIG 3.1.3
Based on published guidance 4 studies
initiated after December 17, 2016, must
be submitted with data formatted in
accordance with the data standards
listed in the FDA Data Standards
Catalog for new drug applications
(NDAs), biologics license applications
(BLAs), and abbreviated new drug
applications (ANDAs). For
investigational new drug applications
(INDs), the requirement 5 applies to
studies initiated after December 17,
2017. Different versions of SENDIGs are
on the Data Standards Catalog, and the
submission of SEND nonclinical
datasets is expected to continue to
increase in the future. This pilot will
evaluate the compliance of sample
SEND–DART datasets submitted to
CDER. As part of this evaluation and in
anticipation of FDA receiving datasets
for regulatory review, the CDISC SEND
team, in collaboration with CDER and
available pilot participants, will update
the SENDIG–DART as needed to include
specific data elements and terms.
1 See the guidance ‘‘Providing Regulatory
Submissions in Electronic Format-Standardized
Study Data; Guidance for Industry’’ at https://
www.fda.gov/media/82716/download.
2 See the CDISC website at https://www.cdisc.org.
3 The updated guide can be found at https://
www.cdisc.org. FDA has verified the website
address, but the Agency is not responsible for any
subsequent changes to the website address after this
document publishes in the Federal Register.
4 See the Technical Rejection Criteria for Study
Data at https://www.fda.gov/media/100743/
download.
5 See footnote 4.
E:\FR\FM\22OCN1.SGM
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Federal Register / Vol. 85, No. 205 / Thursday, October 22, 2020 / Notices
II. Project Participation
CDER is seeking a maximum of five
participants in this pilot. The Center
will use its discretion in choosing
participants based on the completeness
of the submission per the guidelines
below. CDER requests participants to
submit a nonclinical study package
containing the materials:
• SEND–DART v1.1 datasets;
• final related study report containing
individual animal data and summary
tables 6 (PDF Format);
• nonclinical Study Data Reviewers
Guide; 7
• define.xml (v2.0); 8 and
• sample standardization study
protocol.
CDER will prioritize nonclinical
packages that contain Embryo-Fetal
Development (EFD) Toxicity studies
(using pre-bred females only) that
contain data that is consistent with
SEND–DART v1.1. Therefore, the
studies that meet as many of the
following use cases as possible will be
the most sought out as participants in
this pilot:
• Small animals (rodents, rabbits),
pre-bred females, treatment period
during implanted embryo’s major
organogenesis period;
• material toxicity endpoints
(minimum CL, BW, FW, DS);
• caesarean section endpoints in PY,
IC, FM, FX (pregnancy, Corpora Lutea,
implantations, resorptions, fetal
viability, fetal sex and body weights,
fetal morphology);
• toxicokinetic females to illustrate in
Trial Design and pregnancy results (PC,
PP domains optional);
• LB domain optional since not
routine in EFD Toxicity study;
• MA optional (if gross observations
scheduled, may not be in preliminary
EFD study);
• gravid uterine weights (OM
domain) for deriving gravid uterus
adjusted body weight; and
• pregnant, non-pregnant,
toxicokinetic females to illustrate in
Trial Design and pregnancy results (PC,
PP domains optional).
Please indicate in your request for
participation the extent to which your
submission will meet the above listed
criteria. Please also indicate whether
you are willing to share anonymized
data with the CDISC FFU team.
This pilot is intended to inform of the
readiness of the SEND–DART standard
6 See the FDA Study Data Resources web page,
available at https://www.fda.gov/ForIndustry/
DataStandards/StudyDataStandards/default.htm.
7 See the PhUSE Wiki web page, available at
https://www.phusewiki.org/wiki/
index.php?title=Nonclinical_Study_Data_
Reviewers_Guide.
8 See Footnote 6.
VerDate Sep<11>2014
17:35 Oct 21, 2020
Jkt 253001
and support improvements to the
SEND–DART that will benefit FDA and
submitters. Pilot participants commit to
publicly share lessons learned with the
CDISC SEND team to ensure that the
CDISC SEND standard is improved for
the community. Participants may redact
any sensitive information as needed to
enable sharing FDA feedback with the
CDISC SEND team.
III. Requests for Participation
Requests to participate in the SEND–
DART FFU pilot are to be identified
with the Docket No. FDA–2020–N–
1806. Interested persons should include
the following information in the request:
Contact name, contact phone number,
email address, name of the sponsor, and
address, as well as the description of the
criteria met, addressing each of the
items in the Project participation
section.
Once requests for participation are
received CDER will contact interested
sponsors to discuss the pilot project and
clarify requirements and expectations.
The elapsed time duration of the pilot
is expected to be approximately 9
months but may be extended as needed.
Dated: October 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–23393 Filed 10–21–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Proposed Establishment of the
Advisory Committee on Heritable
Disorders in Newborns and Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Proposed Establishment of the
Advisory Committee on Heritable
Disorders in Newborns and Children
(ACHDNC or Committee).
AGENCY:
In accordance with the
Federal Advisory Committee Act
(FACA) and section 1111 of the Public
Health Service (PHS) Act, HHS
announces the establishment of the
ACHDNC as a discretionary advisory
committee.
SUMMARY:
Mia
Morrison (DFO), Maternal and Child
Health Bureau, HRSA, 5600 Fishers
Lane, Rockville, Maryland 20857; 301–
443–2521; or mmorrison@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00028
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67357
The
ACHDNC provides advice and
recommendations to the Secretary of
HHS on policy, program development,
and other matters of significance
concerning certain activities described
in section 1111 of the PHS Act (42
U.S.C. 300b–10), as further described
below. The ACHDNC is also governed
by the provisions of the FACA, as
amended (5 U.S.C. App.), which sets
forth standards for the formation and
use of advisory committees. The
ACHDNC advises the Secretary of HHS
about aspects of newborn and childhood
screening and technical information for
the development of policies and
priorities that will enhance the ability of
the state and local health agencies to
provide for newborn and child
screening, counseling, and health care
services for newborns and children
having, or at risk for, heritable
disorders. The ACHDNC will review
and report regularly on newborn and
childhood screening practices,
recommend improvements in the
national newborn and childhood
screening programs, and fulfill
responsibilities described in section
1111 of the PHS Act. In addition, the
ACHDNC’s recommendations regarding
inclusion of additional conditions for
screening, following adoption by the
Secretary of HHS, are considered
evidence-informed preventive health
services provided for in the
comprehensive guidelines supported by
HRSA through the Recommended
Uniform Screening Panel (RUSP)
pursuant to section 2713 of the PHS Act
(42 U.S.C. 300gg–13). Under this
provision, non-grandfathered group
health plans and health insurance
issuers offering group or individual
health insurance are required to provide
insurance coverage without cost-sharing
(a co-payment, co-insurance, or
deductible) for preventive services for
plan years (i.e., policy years) beginning
on or after the date that is one year from
the Secretary’s adoption of the
condition for screening.
Notice of Establishment: In
accordance with the FACA and section
1111 of the PHS Act, (42 U.S.C. 300b–
10) the Secretary of HHS announces the
proposed establishment of the
ACHDNC.
It has been determined that the
formation of the ACHDNC is in the
public interest in connection with the
performance of duties imposed on the
Department of Health and Human
Services by law. A copy of the ACHDNC
charter can be accessed on the ACHDNC
website once available. A copy of the
charter also can be obtained, once
available, by accessing the FACA
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22OCN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 205 (Thursday, October 22, 2020)]
[Notices]
[Pages 67355-67357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23393]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1806]
Fit for Use Pilot Program Invitation for the Clinical Data
Interchange Standards Consortium for Standard for Exchange of
Nonclinical Data Implementation Guide Developmental and Reproductive
Toxicology: Version 1.1
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that it intends to conduct a Fit for Use (FFU) pilot program to test
the processing and analysis of nonclinical study data provided
electronically for the Clinical Data Interchange Standards Consortium
(CDISC) for Standard for Exchange of Nonclinical Data (SEND)
Implementation Guide (IG): Developmental and Reproductive Toxicology
v1.1 (SEND-DART). The Agency's Center for Drug Evaluation and Research
(CDER) will test the processing and analysis of nonclinical study data
provided electronically in SEND-DART format. FDA is inviting individual
firms that wish to participate in this pilot program to submit
participation requests via email or in writing.
DATES: To be considered for participation in the pilot program, submit
electronic or written requests by February 26, 2021. See the ADDRESSES
section for participation request instructions.
ADDRESSES: Submit electronic requests to participate in the pilot and
comments regarding this pilot project to Docket No. FDA-2020-N-1806 at
https://www.regulations.gov. Submit written requests to participate in
the pilot and comments regarding the pilot to Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time by February
26, 2021. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date.
[[Page 67356]]
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2020-N-1806 for ``Fit for Use Pilot Program Invitation for the
Clinical Data Interchange Standards Consortium for Standard for
Exchange of Nonclinical Data Implementation Guide: Developmental and
Reproductive Toxicology v1.1.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Jesse Anderson, Office of
Computational Science, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 1553,
Silver Spring, MD 20993-0002, 301-348-1816, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Data Standards help FDA receive, process, review and archive
submission data more efficiently and effectively. Study data standards
describe a standard way to exchange clinical and nonclinical research
data between computer systems. These standards provide a consistent
general framework for organizing study data, including templates for
datasets, standard names for variables, and a standard way of doing
calculations with common variables. Study data standards are required
for study data submitted to FDA's CDER per the published guidance.\1\
---------------------------------------------------------------------------
\1\ See the guidance ``Providing Regulatory Submissions in
Electronic Format-Standardized Study Data; Guidance for Industry''
at https://www.fda.gov/media/82716/download.
---------------------------------------------------------------------------
CDISC is an open, multidisciplinary, nonprofit organization that
has established worldwide industry standards to support the electronic
acquisition and submission of study data and metadata for medical and
biopharmaceutical product development.\2\ CDISC is currently
facilitating and testing the extension of the SEND-DART standard for
nonclinical toxicology data.
---------------------------------------------------------------------------
\2\ See the CDISC website at https://www.cdisc.org.
---------------------------------------------------------------------------
CDER completed a pilot project evaluating SEND 3.1 using SEND-
formatted sample toxicology datasets. Phase 1 of the pilot supported
the development of a SEND Implementation Guide (SENDIG) describing the
process for formatting data from single and repeat-dose animal toxicity
and carcinogenicity studies for submission purposes. During Phase 2 of
the pilot, CDER evaluated submission of SEND formatted datasets and
evaluated data validation and analysis tools capabilities. The outcomes
of this pilot resulted in improvements to the SENDIG 3.1.\3\
---------------------------------------------------------------------------
\3\ The updated guide can be found at https://www.cdisc.org. FDA
has verified the website address, but the Agency is not responsible
for any subsequent changes to the website address after this
document publishes in the Federal Register.
---------------------------------------------------------------------------
Based on published guidance \4\ studies initiated after December
17, 2016, must be submitted with data formatted in accordance with the
data standards listed in the FDA Data Standards Catalog for new drug
applications (NDAs), biologics license applications (BLAs), and
abbreviated new drug applications (ANDAs). For investigational new drug
applications (INDs), the requirement \5\ applies to studies initiated
after December 17, 2017. Different versions of SENDIGs are on the Data
Standards Catalog, and the submission of SEND nonclinical datasets is
expected to continue to increase in the future. This pilot will
evaluate the compliance of sample SEND-DART datasets submitted to CDER.
As part of this evaluation and in anticipation of FDA receiving
datasets for regulatory review, the CDISC SEND team, in collaboration
with CDER and available pilot participants, will update the SENDIG-DART
as needed to include specific data elements and terms.
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\4\ See the Technical Rejection Criteria for Study Data at
https://www.fda.gov/media/100743/download.
\5\ See footnote 4.
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[[Page 67357]]
II. Project Participation
CDER is seeking a maximum of five participants in this pilot. The
Center will use its discretion in choosing participants based on the
completeness of the submission per the guidelines below. CDER requests
participants to submit a nonclinical study package containing the
materials:
SEND-DART v1.1 datasets;
final related study report containing individual animal
data and summary tables \6\ (PDF Format);
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\6\ See the FDA Study Data Resources web page, available at
https://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm.
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nonclinical Study Data Reviewers Guide; \7\
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\7\ See the PhUSE Wiki web page, available at https://www.phusewiki.org/wiki/index.php?title=Nonclinical_Study_Data_Reviewers_Guide.
---------------------------------------------------------------------------
define.xml (v2.0); \8\ and
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\8\ See Footnote 6.
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sample standardization study protocol.
CDER will prioritize nonclinical packages that contain Embryo-Fetal
Development (EFD) Toxicity studies (using pre-bred females only) that
contain data that is consistent with SEND-DART v1.1. Therefore, the
studies that meet as many of the following use cases as possible will
be the most sought out as participants in this pilot:
Small animals (rodents, rabbits), pre-bred females,
treatment period during implanted embryo's major organogenesis period;
material toxicity endpoints (minimum CL, BW, FW, DS);
caesarean section endpoints in PY, IC, FM, FX (pregnancy,
Corpora Lutea, implantations, resorptions, fetal viability, fetal sex
and body weights, fetal morphology);
toxicokinetic females to illustrate in Trial Design and
pregnancy results (PC, PP domains optional);
LB domain optional since not routine in EFD Toxicity
study;
MA optional (if gross observations scheduled, may not be
in preliminary EFD study);
gravid uterine weights (OM domain) for deriving gravid
uterus adjusted body weight; and
pregnant, non-pregnant, toxicokinetic females to
illustrate in Trial Design and pregnancy results (PC, PP domains
optional).
Please indicate in your request for participation the extent to
which your submission will meet the above listed criteria. Please also
indicate whether you are willing to share anonymized data with the
CDISC FFU team.
This pilot is intended to inform of the readiness of the SEND-DART
standard and support improvements to the SEND-DART that will benefit
FDA and submitters. Pilot participants commit to publicly share lessons
learned with the CDISC SEND team to ensure that the CDISC SEND standard
is improved for the community. Participants may redact any sensitive
information as needed to enable sharing FDA feedback with the CDISC
SEND team.
III. Requests for Participation
Requests to participate in the SEND-DART FFU pilot are to be
identified with the Docket No. FDA-2020-N-1806. Interested persons
should include the following information in the request: Contact name,
contact phone number, email address, name of the sponsor, and address,
as well as the description of the criteria met, addressing each of the
items in the Project participation section.
Once requests for participation are received CDER will contact
interested sponsors to discuss the pilot project and clarify
requirements and expectations. The elapsed time duration of the pilot
is expected to be approximately 9 months but may be extended as needed.
Dated: October 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23393 Filed 10-21-20; 8:45 am]
BILLING CODE 4164-01-P
